The safety of antidepressant use in pregnancy
The Hospital for Sick Children, The Motherisk Program, Division of Clinical Pharmacology & Toxicology, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada. Expert Opinion on Drug Safety
(Impact Factor: 2.91).
04/2005; 4(2):273-84. DOI: 10.1517/147403126.96.36.1993
Depression during pregnancy affects an estimated 10 - 20% of women, some of whom will require treatment with antidepressants. It is of great importance that the safety of this particular class of drugs is reviewed, to ensure the optimal treatment of the mother while protecting her unborn child. In this review, current safety data on all available antidepressants are discussed in detail, including the pharmacokinetics of the maternal-fetal unit and the epidemiological studies that have been published to date. The classes of antidepressants discussed include: tricyclics, selective serotonin re-uptake inhibitors and other antidepressants. After reviewing these studies, it is evident that these drugs appear to be relatively safe to take during pregnancy. This evidence-based information will be helpful to women and their healthcare providers, when the decision of whether or not to treat with anti-depressants during pregnancy must be made.
Available from: Jeffrey K Aronson
- "Some reviewers have concluded that there is no increased risk in first-trimester exposure   , some that the evidence is conflicting , some that paroxetine is teratogenic and that other SSRIs are not , and others that there may be poor neonatal outcomes . In a case-control study first-trimester exposure to paroxetine was associated with a significantly increased risk of atrial septal defects (adjusted OR ¼ 5.7; 95% CI ¼ 1.4, 24) . "
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ABSTRACT: Observational studies of drug effects are often regarded as inadequate in providing evidence of benefits but accepted as evidence of harms. Important harms that have been suggested by observational studies include teratogenicity of selective serotonin reuptake inhibitors, suicide associated with isotretinoin, and asthma associated with paracetamol. However, in all these cases the evidence is highly variable, and factors such as confounding by indication or selection bias have not been adequately taken into account. Systematic reviews of studies that are subject to confounding are themselves similarly affected. Other examples of drug-event pairs highlighted by observational studies include glucocorticoids and atrial fibrillation, antipsychotic drugs and raised hemoglobin A1C, adverse reactions to proton pump inhibitors plus clopidogrel, psychoactive drugs and memory loss, and adverse reactions to methylphenidate. We should not jump to the conclusion that causation is implied when an event has been attributed to a medication in an observational study, unless the odds ratio is very high or the study has been designed so as to eliminate or at least reduce the likelihood of such factors as confounding and selection bias; whenever possible, studies of adverse drug reactions should be so designed from the start. Furthermore, when adverse reactions are listed in information sources, such as Summaries of Product Characteristics, the level of evidence on which they are based should be stated. If the evidence falls short of proof of an association, it may be appropriate to issue a precautionary warning, making it clear that the association has not been proven.
Available from: PubMed Central
- "To date, based on a fairly substantial body of epidemiologic data, there is no evidence that antidepressants are not safe to take during pregnancy , in fact, emerging data in the literature documents evidence that not taking an antidepressant if it is warranted may be more harmful. The decision to discontinue taking an antidepressant during pregnancy can have deleterious effects on both the health of the mother and her baby as untreated depression during pregnancy carries its own risks. "
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ABSTRACT: On Aug 9th 2004 Health Canada released an advisory, which followed a similar one from the FDA regarding the use of SSRI's and other antidepressants during pregnancy and potential adverse effects on newborns. In neither advisory was it stated that women should discontinue their antidepressant. In the seven days following the release of this advisory, The Motherisk Program received 49 calls from anxious women in response to the media reporting of this information.
To examine the impact of the advisory and subsequent reporting in the media, on the decision-making of women, currently taking an antidepressant, who called The Motherisk Program after becoming aware of this information.
We attempted to follow up all the women who had called us who were alarmed by this advisory and asked them to complete a specially designed questionnaire.
We were able to complete 43/49 (88%) follow-ups of the women who contacted us. All of the callers reported that the messages in the media caused a great deal of anxiety. Seven misunderstood the advisory, ie their children were more than 1 year old, five had discontinued their antidepressant (3 abruptly (2 later restarted after speaking with Motherisk counsellors)and 2 with some form of tapering off) and(6) were considering discontinuation, but decided to continue following reassurance from Motherisk
Medical information regarding fetal and infant safety, disseminated in the public domain, should be transferred in a way that does not influence a pregnant woman to make decisions that may not be in the best interest of hers or her child's health.
Available from: William R Marchand
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